EUCTR2021-002614-13-IT进行中（未招募）1 期
Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial - ElechtraPlatinum
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI0 个研究点目标入组 70 人开始时间: 2021年12月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Age = 18 years old
- •2.Recurrent vulvar carcinoma confirmed by histological examination (sec. WHO 2020)
- •3.Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), alternatively patient not eligible for standard therapies due to the performance
- •4.Status life expectancy more than three months
- •5.Measurable disease according to RECIST 1.1
- •6.Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows:
- •- Bone marrow (Hemoglobin = 8.0 g/dL with or without transfusion support, Platelet count = 75 × 109/L?)
- •- INR> 1,5
- •- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) =3.0 × upper limit of normal (ULN)
- •- Total bilirubin =2.0 × ULN or =3 × ULN except for subjects with Gilbert’s
- •- Serum creatinine <1.5 mg/dl
- •7.For females of childbearing potential, a pregnancy test on negative serum within 15 days of Day 1 of the study.
- •8.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply the study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
- •2.History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
- •3.Allergic reactions to the two chemotherapy drugs (BLM and CBP) and/or their excipients.
- •4.Evidence of pulmonary fibrosis.
- •5.History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification =II [NYHA 1994]), myocardial infarction within 6 months of study entry.
- •6.Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded).
- •7.Pregnant or breastfeeding.
- •8.Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study.
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